Acetyl - Generic Drug Details

See drug prices for acetyl

Generic filers with tentative approvals for ACETYL

Applicant	Application No.	Strength	Dosage Form
		6GM/30ML (200MG/ML)	INJECTABLE;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for acetyl

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	ACETYLCYSTEINE	acetylcysteine	INJECTABLE;INTRAVENOUS	203173-001	Mar 24, 2015	AP	RX	No	No
Regcon Holdings	ACETYLCYSTEINE	acetylcysteine	INJECTABLE;INTRAVENOUS	215620-001	Feb 23, 2022	AP	RX	No	No
Roxane	ACETYLCYSTEINE	acetylcysteine	SOLUTION;INHALATION, ORAL	072323-001	Apr 30, 1992		DISCN	No	No
Somerset Theraps Llc	ACETYLCYSTEINE	acetylcysteine	SOLUTION;INHALATION, ORAL	219194-002	Feb 12, 2025	AN	RX	No	No
Dey	MUCOSIL-10	acetylcysteine	SOLUTION;INHALATION, ORAL	070575-001	Oct 14, 1986		DISCN	No	No
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes
Am Regent	ACETYLCYSTEINE	acetylcysteine	SOLUTION;INHALATION, ORAL	072489-001	Jul 28, 1995	AN	RX	No	Yes